ISRCTN64716212已完成未知
An international multi-centre, randomised, double-blind, placebo controlled trial to evaluate the efficacy and safety of 0.5% and 2% Pro 2000/5 gels for the prevention of vaginally acquired human immunodeficiency virus (HIV) infections
Medical Research Council (MRC) (UK)0 个研究点目标入组 9,673 人开始时间: 2005年7月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 9,673
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Sexually active
- •2. HIV-negative healthy women
- •3. Not pregnant
排除标准
- •1. Unable or unwilling to provide a reliable method of contact for the field team
- •2. Likely to move permanently out of the area within the next year
- •3. Likely to have sex more than 14 times a week on a regular basis during the course of follow-up
- •4. Using spermicides regularly
- •5. Pregnant or within 6 weeks postpartum at enrolment
- •6. Has grade 3 clinical or laboratory abnormalities which are considered by the clinician or the Trial Management Group to make enrolment inadvisable
- •7. Requiring referral for assessment of a clinically suspicious cervical lesion
- •8. Treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment
- •9. Known latex allergy
- •10. Participating, or having participated within 30 days of enrolment, in a clinical trial of an unlicensed product, microbicide, barrier method or any other intervention likely to impact on the outcome of this trial
- •11. Considered unlikely to be able to comply with the protocol
研究者
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