Randomized Controlled Trial of SAVVY and HIV in Ghana

Biosyn2 个研究点分布在 1 个国家目标入组 2,142 人开始时间: 2004年1月1日最近更新: 2005年9月8日

适应症

试验速览

阶段: 3 期
发起方
入组人数: 2,142
试验地点: 2
主要终点: combined incidence of HIV-1 and HIV-2

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

详细描述

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 multi-center, fully-masked, randomized, placebo controlled trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double

入排标准

年龄范围: 18 Years 至 35 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•18 to 35 year old women
•HIV negative
•More than one sexual partner in past 3 months
•Average of 3 coital acts per week
•Willing to use vaginal gel and condoms for 12 months

排除标准

•HIV positive

结局指标

主要结局

combined incidence of HIV-1 and HIV-2

次要结局

未报告次要终点

研究者

发起方

Biosyn

申办方类型

Industry

研究点 (2)

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