NCT00130078Unknown3 期
Randomized Controlled Trial of SAVVY and HIV in Nigeria
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9月1日最近更新:
适应症
相关药物
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
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 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
研究点 (2)
Loading locations...
相似试验
Unknown
3 期
Trial of SAVVY and HIV in GhanaHIV InfectionsNCT00129532Biosyn2,142
已完成
2 期
BufferGel and PRO 2000/5: Vaginal Gels to Prevent HIV Infection in WomenHIV InfectionsNCT00074425National Institute of Allergy and Infectious Diseases (NIAID)3,101
已完成
2 期
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive AdultsHIV InfectionsNCT03784079ViiV Healthcare34
终止
1 期
Thai Prophylactic HIV Vaccine Phase I StudyHIVNCT00333424Kirby Institute8
已完成
4 期
A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, ThailandHIVHerpesNCT00362596Centers for Disease Control and Prevention67